Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Job description:
The Process Validation Scientist III supports process validation (PV) activities to enable technology transfer of customer processes into Lonza Vacaville or validate changes for commercial customers. This role collaborates closely with customers to identify and resolve process validation challenges.
Key responsibilities:
Process Validation Documentation: Protocol Generation, Execution, and Reporting (Analysis)
Author protocols, implement studies, analyze data, and write reports. May require guidance on varied tasks, while increasingly handles small projects independently or with limited oversight.
Able to perform intermediate level data analysis e.g. nonstandard calculations, means comparison, control charting.
Intermediate knowledge of subject area including regulations, guidance documents, and understanding of their purpose.
Quality Systems
Discrepancies: Process validation discrepancies or investigations and resolve discrepancies by working with senior staff when needed.
Deviations and Change controls: Assess minor deviations and change controls with minimal assistance. May need some review and oversight or feedback from senior staff.
CAPA: Ability to work with assistance and supervision on moderate CAPA that results from deviations, internal audits, protocol discrepancies, global quality audits or regulatory inspections.
SOPs: Independently authors, reviews, revises, and approves SOPs.
Customer Meetings, Audits & Inspections
Represents PV on project teams and collaborates with customer technical and quality representatives.
Represents Process Validation on internal teams.
Participates in customer audits and regulatory inspections.
Training and Regulatory compliance
Follows all training and policy guidelines established for the facility as well as all cGMP requirements.
Familiarity with cGMP, regulatory guidelines (FDA, EMA, and ICH) and industry guidelines (BPOG, PDA, and ISPE).
Experience with assisting review BLA or APR reporting.
Key requirements:
Bachelor's degree in Chemical Engineering, Mechanical, Biology, Biochemistry, life sciences or relevant field.
4-7 years of biotech proven experience in process validation, process development, or manufacturing.
Experience supporting large-scale manufacturing (2KL+ mammalian preferred) with knowledge of cGMP and US/EU regulations.
Ability to write clear, concise technical writing to support validation methods under the guidance of senior staff, ensuring compliance with regulatory and customer expectations.
Strong communication, and proficiency in MS Office Suite.
Responsible for defining and implementing methods of process validation for different projects under supervision of higher staff which will be scrutinized by regulatory bodies and customers.
Requires basic understanding of all applicable QC assays.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
We recognize that attracting, developing, and retaining the best talent is key to our strategy and success as a company. As a result, we aim for flexibility in structuring competitive compensation offers to ensure that we are able to attract the best candidates. As required by law in this state, the quoted salary range for this position is $95,000 to $153,000. We use broad salary ranges that reflect the competitive market for similar jobs, provide sufficient opportunity for growth as you gain experience and expand responsibilities; while also allowing for differentiation on performance based on the breadth of our ranges, most new hires will start at the company between the lower and the middle part of the applicable range. We tailor our offers within the range based on job-related factors, including organizational needs, internal equity, market data, geographic area and the selected candidate’s experience, education, industry knowledge, location, technical and/or communication skills and other factors that may prove relevant during the selection process. This range is only inclusive of base salary, and base pay is just one component of Lonza’s total compensation package for employees. Full-time employees are eligible to receive a performance-related bonus, as well as a comprehensive benefits package including medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.